The Sr. Software Quality Engineer will be responsible for performing project management tasks for the entire software development lifecycle in a regulated medical device environment with focus on documentation, quality assurance, and validation activities, including participation in regulatory submissions.
Essential Duties and Responsibilities:
Develop and maintain strong internal working relationships across the company.
Understand the objectives, responsibilities, and mission of the Software
Development department and work towards those goals.
Prioritize and plan work activities; adapt for changing conditions.
Lead team of software quality engineers.
Hands-on manager with primary responsibilities focused on providing guidance and direction to a small, fast-paced, hardworking, and highly technical team.
Mentor team members on best practices and standards used throughout the product development lifecycle.
Perform SDLC project management activities.
Coordinate software test and validation activities.
Process software related CAPA’s.
Manage defect tracking and triaging.
Work with appropriate stakeholders in CAD/Engineering to develop testing and validation strategies and quality plans for implant/instrumentation design software applications and provide direction to software engineers in their implementation.
Work with stakeholders to review, analyze, and complete application
documentation and software quality deliverables for multiple projects, such as user needs, requirements, design documents, user manuals, risk assessments, and project and validation plans.
Perform technical writing activities and thoroughly review documentation in support of regulatory submissions.
Perform software risk analysis activities.
In collaboration with the QA department, maintain and improve SDLC and software quality assurance in compliance with FDA regulation and other regulatory requirements.
Act as an effective hands-on member of a cross-functional team who is directly involved in the application development life cycle.
Ensure compliance of all activities with applicable regulations and standards.
Work closely with the product development team (Engineering/product
management/manufacturing/documentation) for release planning, resolving issues and mitigating project risks.
Other responsibilities as assigned.
Bachelor's degree or higher (preferably in a technical or quantitative field).
5+ years’ experience in software QA, including medical device software.
5+ years’ experience in leading/managing project team(s) in a technical
2+ years’ experience preparing submission-grade software documentation.
Extensive experience preparing software verification/validation documentation.
Skills, Abilities, Competencies Required:
Excellent written and verbal communication skills.
Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness.
Strong project management skills.
Excellent technical writing skills with great attention to detail in English.
Familiarity with IEC 62304 and medical device design controls.
Knowledge of software quality engineering and testing methods at all levels (unit, integration, system, V&V, acceptance) applied within the software development lifecycle.
Ability to understand end-user and application usage scenarios for use in design and conduct of software testing.
Strong organizational, analytical, and time-management skills.
Able to self-motivate and work both independently and as part of a team.
Must have expert and proven technical leadership skills and demonstrated ability to complete projects on schedule.
Strong leadership skills that inspire team confidence and respect while motivating team members in a creative and effective manner.
Demonstrated sense of urgency, resourcefulness, and circumventing obstacles.
Respond productively to repeated changes in directions and regressions in progress. Deal well with ambiguity.